ABBOTT LABORATORIES DIAGNOSTICS DIVISION: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
Família Alinity i Tacrolimus 80146502271	Tacrolimus	III	ABBOTT LABORATORIOS DO BRASIL LTDA	10/08/2020	Until 10/08/2030
Alinity i Cyclosporine Whole Blood Precipitation Reagent Kit 80146502246	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	20/02/2020	Valid
Família ARCHITECT Tacrolimus 80146502080	Tacrolimus	III	ABBOTT LABORATORIOS DO BRASIL LTDA	26/02/2018	Until 26/02/2028
ALINITY S SYSTEM 80146502070	Immunoassay instrument	II	ABBOTT LABORATORIOS DO BRASIL LTDA	22/01/2018	Valid
CELL-DYN 22 Plus Control 80146501994	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	17/05/2017	Valid
CELL-DYN 22 Plus Calibrator 80146501988	Multi-analyte calibrators and standards, one or more concentrations - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	02/05/2017	Valid
LIPID MULTICONSTITUENT CALIBRATOR 80146501919	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	02/03/2015	Valid
MAGNESIUM 80146501793	Magnesium	II	ABBOTT LABORATORIOS DO BRASIL LTDA	09/07/2012	Valid
CELL-DYN 18 Plus Calibrator / CELL-DYN 18 Plus Calibrador 80146501580	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	30/03/2009	Valid
CELL-DYN 18 Plus Control (Low, Normal, High) 80146501581	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	30/03/2009	Valid
CELL-DYN 26 Plus Control (Low, Normal and High) 80146501579	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	23/03/2009	Valid
ACID PHOSPHATASE 80146501540	Total acid phosphatase (TAP)	II	ABBOTT LABORATORIOS DO BRASIL LTDA	25/08/2008	Valid
ARCHITECT Sirolimus Whole Blood Precipitation Reagent 80146501538	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	11/08/2008	Valid
ARCHITECT Sirolimus Calibrators 80146501531	Sirolimus	III	ABBOTT LABORATORIOS DO BRASIL LTDA	28/07/2008	Until 28/07/2033
ARCHITECT Sirolimus Reagent Kit 80146501532	Sirolimus	III	ABBOTT LABORATORIOS DO BRASIL LTDA	28/07/2008	Until 28/07/2033
ARCHITECT T-UPTAKE CONTROLS / ARCHITECT T-UPTAKE CONTROLES 80146501384	Thyroxine (T4)	II	ABBOTT LABORATORIOS DO BRASIL LTDA	27/11/2006	Valid
ARCHITECT T-UPTAKE CALIBRATORS / ARCHITECT T-UPTAKE CALIBRADORES 80146501385	Thyroxine (T4)	II	ABBOTT LABORATORIOS DO BRASIL LTDA	27/11/2006	Valid
CELL-DYN 29 PLUS CONTROL (WITH RETIC) - CELL-DYN 29 PLUS CONTROLE (COM RETIC) 80146501310	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	21/11/2005	Valid
CELL-DYN HemCal PLUS CALIBRATOR - CELL-DYM HemCal PLUS CALIBRADOR 80146501311	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	21/11/2005	Valid
CELL-DYN SAPPHIRE 80146501299	Cell and platelet analyzer or counter	II	ABBOTT LABORATORIOS DO BRASIL LTDA	17/10/2005	Valid
ABBOTT CLINICAL CHEMISTRY APO A1/APO B CALIBRATOR/APO A1/APO B CALIBRADOR ABBOTT BIOQUIMICA 80146501276	Apolipoprotein A-I	II	ABBOTT LABORATORIOS DO BRASIL LTDA	18/08/2005	Valid
ABBOTT CLINICAL CHEMISTRY LIPASE CALIBRATOR - LIPASE CALIBRADOR ABBOTT BIOQUIMICA 80146501257	Lipase	II	ABBOTT LABORATORIOS DO BRASIL LTDA	27/06/2005	Valid
ABBOTT CLINICAL CHEMISTRY LIPASE REAGENT KIT/LIPASE REAGENTE ABBOTT BIOQUIMICA 80146501195	Lipase	II	ABBOTT LABORATORIOS DO BRASIL LTDA	06/12/2004	Valid
IRON/MAGNESIUM CALIBRATOR-FERRO/MAGNÉSIO CALIBRADOR 10055310924	Iron	II	ABBOTT LABORATORIOS DO BRASIL LTDA	28/10/1999	Valid
ICT SAMPLE DILUENT / ICT DILUENTE DE AMOSTRA 10055310939	Buffers, diluents and other solutions for laboratory analysis	I	ABBOTT LABORATORIOS DO BRASIL LTDA	28/10/1999	Valid
PHOSPHORUS / FÓSFORO 10055310843	Inorganic phosphorus/phosphate	II	ABBOTT LABORATORIOS DO BRASIL LTDA	06/05/1999	Valid
GLUCOSE / GLICOSE 10055310845	Glucose	II	ABBOTT LABORATORIOS DO BRASIL LTDA	06/05/1999	Valid

ABBOTT LABORATORIES DIAGNOSTICS DIVISION

Brazilian registration holders

Device types

Registrations